BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4073259 · Received September 9, 2014

    Report

    Report Number
    2032227-2014-18339
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD AN ABSENCE OF NO DELIVERY ALARM. THE BLOOD GLUCOSE READING WAS 218 MG/DL. THE CUSTOMER STATED THAT SHE HAD ISSUES WITH THE INFUSION SETS BEING OCCLUDED AND THAT WHEN SHE ATTEMPTED TO PRIME, NOTHING CAME FROM THE CANNULA. SHE NOTED THAT SHE DID NOT HAVE THE TUBING CLAMP NECESSARY TO CONTINUE TROUBLESHOOTING. ADVISED THE CUSTOMER TO MONITOR THE INSULIN PUMP UNTIL TROUBLESHOOTING COULD BE COMPLETED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553781 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR